J&J, Sanofi Top Bioethics International Transparency Report
Johnson & Johnson continues to be one of the most transparent biotech companies when it comes to sharing clinical trial data. The company topped the Bioethics International “Good Pharma Scorecard” for the second time in a row.
This is the second year Bioethics International released its rankings. The pro-transparency organization released the report in BMJ Open two years ago and J&J topped the list of companies with a perfect score.
Janssen, J&J’s pharma subsidiary, has long pushed to be a transparent company. Earlier this year, Janssen released its first annual transparency report that highlights its pricing and marketing practices, patient access programs and costs of the company’s clinical trials.
By being more transparent about the costs of a drug, from discovery to commercialization, Janssen will be in a greater position to work with its stakeholders and become advocates for improvements Rebecca Tillet, regional pharmaceuticals communication and public affairs leader for Janssen, told BioSpace earlier this year.
J&J Chief Medical Officer Joanne Waldstreicher said her company believes sharing clinical trial data honors the patients who participated in the trial and contributes to improving patient care.
“The Good Pharma Scorecard transparency standards match our own standards, and we recognize the work Bioethics International is doing to shine a light on transparency in the industry,” Waldstreicher said in a statement.
Surprisingly, J&J wasn’t the only company to top the list. Sanofi joined it at the top of the list. That was a remarkable turnaround given that two years ago Sanofi was considered one of the least transparent companies by Bioethics International.
“We were really surprised and excited to see that turnaround in Sanofi,” Jennifer Miller, founder of Bioethics International, told BioSpace. “We didn’t expect to see so many positive changes so quickly.”
The 2017 Bioethics International report evaluated data from the 20 largest companies by market cap. The report examined clinical trial registration, results reporting, clinical study report synopsis sharing, as well as journal article publication rates for new drugs approved by the Food and Drug Administration in 2014.
In comparing the 2017 GPS report to the first one in 2015, data showed meaningful progress has been made on several key metrics. The proportion of new drugs with all Phase II or III trials disclosed from their New Drug Applications rose to 67 percent this year from 50 percent in 2015. Additionally, the report showed public availability of results for trials conducted in patients for each drug, went up from a median of 87 percent to 96 percent. That data was measured at 13 months post-FDA approval. Disclosure rates for trials in patients were 65 percent at FDA approval and improved significantly by three months post-FDA approval to 85 percent.
There was little change in transparency levels for the "all trials" standard, which included evaluating Phase I trials conducted in healthy volunteers. The median proportion of all trials with public results went from 65 percent to 68 percent.
Rounding out the top five companies behind J&J and Sanofi are AbbVie, Celgene and Merck. J&J and Sanofi both scored 100 percent on the GPS ranking. AbbVie, Celgene, Merck and AstraZeneca all scored at or above the industry median.
Miller said the Good Pharma Scorecard was created to advance trustworthiness and ethics in the pharma industry. By establishing clear standards of transparency Miller said it will be beneficial for public confidence in companies as well as for evidence-based medicine. Miller added that having evidence available will benefit R&D efforts because companies will not have to waste resources if another company has followed a developmental trail to a dead-end. She said publishing data can also prevent patients from being exposed to any unnecessary risks from a trial that may have previously failed but was not disclosed.
“You need all the evidence about new drugs in the public domain,” she said.
Miller said in general companies are responding to calls for transparency and improving their internal practices
“This year's scorecard shows clear corporate leaders in clinical trial transparency and industry improvement on several metrics. We hope this improvement continues year after year because clinical trial transparency is critical for advancing innovation, respect for trial participants, and patient health,” she said.
Miller is hoping the GPS will become an annual report. She and her colleagues are already planning for the 2018 report, which will include a requirement of patient-level data sharing. Miller said they also intend to broaden the scorecard beyond the large market cap companies and include smaller companies in the report.
“Sunlight is a good disinfectant, but it’s not always enough, you need other things to incentivize change,” Miller said.